NCT05888649

Brief Summary

This community-based mixed methods study intends to identify, explore, and assess the determinants of community preparedness for outbreak situations, including acceptance for Ebola vaccines.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 5, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

June 5, 2023

Status Verified

May 1, 2023

Enrollment Period

1.9 years

First QC Date

April 27, 2023

Last Update Submit

May 24, 2023

Conditions

Keywords

Community PreparednessOutbreak ResponseEbola Virus Disease (EVD)Ebola VaccineEbola Vaccine AcceptanceCommunity LeadersLiberia

Outcome Measures

Primary Outcomes (2)

  • Measure #1

    Assess Community Preparedness with the Resiliency Scale

    2 Years

  • Measure #2

    Assess Community Acceptance of EVD Vaccine with the Resiliency Scale

    2 Years

Secondary Outcomes (2)

  • Measure #3

    2 Years

  • Measure #4

    2 Years

Study Arms (4)

Cluster 1

Communities highly affected and impacted by EVD

Behavioral: Community Clusters

Cluster 2

Communities not highly affected and impacted by EVD

Behavioral: Community Clusters

Cluster 3

Communities receptive to EVD vaccination

Behavioral: Community Clusters

Cluster 4

Communities resistance to EVD vaccination

Behavioral: Community Clusters

Interventions

Assessment of the determinants for community preparedness to EVD outbreaks and acceptance of EVD vaccines.

Also known as: Community Cohorts
Cluster 1Cluster 2Cluster 3Cluster 4

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Health adults (males and females)

You may qualify if:

  • Adults
  • Community Leaders
  • Community Members
  • Reside in 1 of 3 highly prevalent counties
  • Participated actively in EVD outbreaks related activities
  • Documented roles recognized by the Incident Management System

You may not qualify if:

  • Not Adults
  • Does not reside in any of the 3 highly prevalent counties
  • Did not actively participate in the EVD outbreak response related activities
  • Roles not documented by the Incident Management System

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montserrado, Margibi and Lofa Counties

Monrovia, Montserrado County, 1000, Liberia

Location

Related Publications (10)

  • Kennedy SB, Neaton JD, Lane HC, Kieh MW, Massaquoi MB, Touchette NA, Nason MC, Follmann DA, Boley FK, Johnson MP, Larson G, Kateh FN, Nyenswah TG. Implementation of an Ebola virus disease vaccine clinical trial during the Ebola epidemic in Liberia: Design, procedures, and challenges. Clin Trials. 2016 Feb;13(1):49-56. doi: 10.1177/1740774515621037. Epub 2016 Jan 14.

  • Nyenswah T, Fallah M, Sieh S, Kollie K, Badio M, Gray A, Dilah P, Shannon M, Duwor S, Ihekweazu C, Cordier-Lassalle T, Shinde SA, Hamblion E, Davies-Wayne G, Ratnesh M, Dye C, Yoder JS, McElroy P, Hoots B, Christie A, Vertefeuille J, Olsen SJ, Laney AS, Neal JJ, Yaemsiri S, Navin TR, Coulter S, Pordell P, Lo T, Kinkade C, Mahoney F; Centers for Disease Control and Prevention (CDC). Controlling the last known cluster of Ebola virus disease - Liberia, January-February 2015. MMWR Morb Mortal Wkly Rep. 2015 May 15;64(18):500-4.

  • O'Dowd A. Infectious diseases are spreading more rapidly than ever before, WHO warns. BMJ. 2007 Sep 1;335(7617):418. doi: 10.1136/bmj.39318.516968.DB. No abstract available.

  • Kennedy SB, Nisbett RA. The Ebola epidemic: a transformative moment for global health. Bull World Health Organ. 2015 Jan 1;93(1):2. doi: 10.2471/BLT.14.151068. No abstract available.

  • Fregonese F. Community involvement in biomedical research conducted in the global health context; what can be done to make it really matter? BMC Med Ethics. 2018 Jun 15;19(Suppl 1):44. doi: 10.1186/s12910-018-0283-4.

  • Dickert N, Sugarman J. Ethical goals of community consultation in research. Am J Public Health. 2005 Jul;95(7):1123-7. doi: 10.2105/AJPH.2004.058933. Epub 2005 Jun 16.

  • Wills C, Tyeku V. Community participation is essential in clinical trials. BMJ. 2000 Sep 30;321(7264):833. No abstract available.

  • Esangbedo DO, Ughasoro MD, Tagbo BN, Olowu A, Anikene C, Iwegbulam CC. Health-Care Workers' Perspectives on Ebola Virus Vaccine: A Focus Group and In-Depth Interview Interventional Study. Am J Trop Med Hyg. 2016 Sep 7;95(3):654-62. doi: 10.4269/ajtmh.16-0206. Epub 2016 Jul 5.

  • Chiam AL, Cheng NWI, Larson H. Community engagement for outbreak preparedness and response in high-income settings: A systematic review. Glob Public Health. 2022 Jul;17(7):1113-1135. doi: 10.1080/17441692.2021.1919734. Epub 2021 May 2.

  • PREVAIL III Study Group; Sneller MC, Reilly C, Badio M, Bishop RJ, Eghrari AO, Moses SJ, Johnson KL, Gayedyu-Dennis D, Hensley LE, Higgs ES, Nath A, Tuznik K, Varughese J, Jensen KS, Dighero-Kemp B, Neaton JD, Lane HC, Fallah MP. A Longitudinal Study of Ebola Sequelae in Liberia. N Engl J Med. 2019 Mar 7;380(10):924-934. doi: 10.1056/NEJMoa1805435.

MeSH Terms

Conditions

Hemorrhagic Fever, Ebola

Condition Hierarchy (Ancestors)

Hemorrhagic Fevers, ViralRNA Virus InfectionsVirus DiseasesInfectionsFiloviridae InfectionsMononegavirales Infections

Study Officials

  • Stephen B Kennedy, MD, MPH

    UL-PIRE Africa Center, University of Liberia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephen B Kennedy, MD, MPH

CONTACT

Hannah Berrian, MPH

CONTACT

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2023

First Posted

June 5, 2023

Study Start

June 1, 2023

Primary Completion

April 30, 2025

Study Completion

April 30, 2025

Last Updated

June 5, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations